Herpes Zoster
Conditions
Keywords
Immunogenicity, Safety, Long term follow-up, Adults, Herpes zoster
Brief summary
The purpose of this study is to evaluate the persistence of immune response to the HZ vaccine as well as safety up to 10 years after the first dose of initial vaccination course. This study will also assess immune responses after re-vaccination with 2 additional doses of the HZ/su administered at ten years after first dose of initial vaccination course from study Zoster-003 (NCT00434577).
Detailed description
In this LTFU study (ZOSTER-060), subjects who received 2 doses of HZ/su in the earlier Zoster-003 (NCT00434577) study will be followed up at Month 108/Year 9 and Month 120/Year 10 post first dose of vaccine for safety and immunogenicity (humoral and cellular). In order to assess the effect of re-vaccination with 2 additional doses of HZ/su vaccine, all the subjects will receive 2 additional doses of the HZ/su vaccine, on a 0, 2-month schedule at ten years after the initial vaccination course in study Zoster-003 (NCT00434577), and will be followed for reactogenicity, safety and humoral and cellular immunogenicity (including persistence). In alignment with the previous persistence timepoints, this study has no control group.
Interventions
BIOLOGICALHerpes Zoster Vaccine GSK1437173A
Intramuscular injection
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
68 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits, ability to have scheduled contacts to allow evaluation during the study). Or subjects with a caregiver who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the diary cards, vaccination visits, availability for follow-up contacts). * Written informed consent obtained from the subject prior to performance of any study specific procedure. * Previous participation in study ZOSTER-003 (NCT00434577), in group 50 µg gE / AS01B, and who completed the vaccination course (2 doses of HZ/su) in study ZOSTER-003 (NCT00434577). * Subjects are expected to enter the study (or complete Visit 1) as of the time they turn 108 months after first vaccination of previous vaccination course with HZ/su and not later than 111 months.
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine during the period starting 30 days before the first study visit (Day -29 to Day 0), or planned use during the study period. * Use or anticipated use of immunosuppressants or immune-modifying drugs during the period starting six months prior to study start and during the whole study period. This includes chronic administration of corticosteroids (\>14 consecutive days of prednisone at a dose of ≥20 mg/day \[or equivalent\]), long-acting immune-modifying agents (e.g., infliximab) or immunosuppressive/cytotoxic therapy (e.g., medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders). * Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., malignancy, human immunodeficiency virus \[HIV\] infection). * Administration or planned administration of a live vaccine in the period starting 30 days before the first dose of study vaccine and ending 30 days after the last dose of study vaccine, or, administration or planned administration of a non-replicating vaccine\* within 8 days prior to or within 14 days after either dose of study vaccine. E.g., inactivated and subunit vaccines, including inactivated and subunit influenza vaccines and pneumococcal conjugate vaccines. * Previous vaccination against HZ since initial vaccination in Zoster-003. * Administration of immunoglobulins and/or any blood products during the period starting 3 months before the study start, or planned administration during the study period. * History of previous HZ.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anti-glycoprotein (gE) Specific Antibody (Ab) Concentrations | At Month 108 post first dose of initial vaccination course in study Zoster-003 (NCT00434577). | Anti-glycoprotein E (gE) Ab concentrations were determined by Enzyme-Linked Immunosorbent Assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micro international units per milliliter (mIU/mL). |
| Frequencies of gE (Glycoprotein)-Specific Cluster of Differentiation (CD4) (2+) T-cells. | At Month 108 post first dose of initial vaccination course in study Zoster-003 (NCT00434577). | gE specific CD4 (2+) T-cells expressing at least 2 activation markers among IFN-γ, IL-2, TNF-α and CD40L, were determined by means of Intracellular Cytokine Staining (ICS) and expressed in T-cells/million cells. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Any Serious Adverse Events (SAEs) Related to Study Participation or to a Concurrent GSK Medication/Vaccine (Including GSK1437173A Administered During the Zoster-003 [NCT00434577] Study). | Between Months 108 and 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577). | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Anti-gE Specific Antibody (Ab) Concentrations | At 1 month post each re-vaccination dose (i.e. Month 121 and Month 123) and at 1 year post last re-vaccination dose (i.e., Month 134). | Anti-gE antibody concentrations were determined by ELISA in all subjects, presented as GMCs and expressed in mIU/mL. |
| Frequencies of Antigen-specific CD4 (2+) T-cells, Post Re-vaccination Course. | At 1 month post each re-vaccination dose (i.e. Month 121 and Month 123) and at 1 year post last re-vaccination dose (i.e., Month 134). | Antigen specific CD4 (2+)T cells were determined by means of ICS and expressed in T-cells/million cells. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Within 7 days (Days 0-6) after each vaccination and across doses, in the current study. | Assessed solicited local symptoms included: pain, redness and swelling at injection site. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest, prevented normal every day activities. Grade 3 redness/swelling = symptoms spreading beyond a surface of (\>) 100 millimeters (mm). |
| Anti-glycoprotein (gE) Specific Antibody (Ab) Concentrations by Each Age Category | At Months 108 and 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577). | Anti-gE Ab concentrations as determined by ELISA by each age category (60-69 years of age \[YOA\] and ≥70 YOA at the time of initial vaccination).Antibody concentrations were presented as GMCs and expressed in mIU/mL. |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) According to the Medical Dictionary for Regulatory Activities (MedDRA) Classification in All Subjects. | Within 30 days (Days 0-29) after each vaccination in the current study. | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. |
| Number of Subjects With Any, Related and Fatal SAEs. | From Dose 1 of re-vaccination (Month 120) until study end (Month 134). | SAEs assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. |
| Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs). | From Dose 1 of re-vaccination (Month 120) until study end (Month 134). | pIMDs assessed includes AEs that were autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Related pIMDs= pIMDs assessed by the investigator as related to the vaccination. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Within 7 days (Days 0-6) after each vaccination and across doses, in the current study. | Assessed solicited general symptoms included: fatigue, gastrointestinal symptoms \[nausea, vomiting, diarrhoea and/or abdominal pain\], headache, myalgia, shivering and temperature \[higher than or equal to (≥) 37.5 degrees Celsius (°C) for axillary, oral or tympanic route\] and ≥38.0°C for rectal route. Grade 3 fatigue, gastrointestinal symptoms, headache, myalgia, shivering = symptoms that prevented normal activity. Grade 3 temperature = defined as fever higher than (\>) 39.0°C, regardless of the route used. |
| Frequencies of Antigen-specific CD4 (2+) T-cells by Each Age Category | At Months 108 and 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577). | Antigen specific CD4 (2+) T-cells as determined by means of ICS and expressed in T-cells/million cells, by each age category (60-69 YOA and ≥ 70 YOA at the time of initial vaccination). |
Countries
Czechia, Germany, Sweden
Participant flow
Recruitment details
Subjects who participated in the parent study Zoster-003 (NCT00434577),in GSK1437173A \_MD Group and received a complete vaccination course(2 doses of 50 µg GSK1437173A) were offered participation in this Long Term Follow-Up study. A total of 70 subjects met the eligibility criteria & consented to participate in Germany, Sweden and Czech Republic
Pre-assignment details
Out of 70 subjects originally enrolled (Total enrolled cohort for persistence phase) into the study, 8 subjects were eliminated as subject number was allocated without vaccine administration. Only 62 subjects were vaccinated with at least one dose, forming the Total vaccinated cohort(TVc) for re-vaccination phase.
Participants by arm
| Arm | Count |
|---|---|
| GSK1437173A Vaccine Group Subjects who completed vaccination course of 2 doses of HZ/su vaccine (group 50 µg gE/AS01B) in the study Zoster-003 (NCT00434577) were included in this study. 62 of these subjects further received 1 or 2 additional doses of HZ/su vaccine in the revaccination phase of this study | 70 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Not vaccinated but subject ID assigned | 8 |
| Overall Study | Withdrawal by Subject | 1 |
| Overall Study | Withdrawal following SAE | 2 |
Baseline characteristics
| Characteristic | GSK1437173A Vaccine Group |
|---|---|
| Age, Continuous | 72.3 Years STANDARD_DEVIATION 4.3 |
| Race/Ethnicity, Customized White-Caucasian/European Heritage | 70 Participants |
| Sex: Female, Male Female | 43 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 62 |
| other Total, other adverse events | 53 / 62 |
| serious Total, serious adverse events | 7 / 62 |
Outcome results
Primary
Anti-glycoprotein (gE) Specific Antibody (Ab) Concentrations
Anti-glycoprotein E (gE) Ab concentrations were determined by Enzyme-Linked Immunosorbent Assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micro international units per milliliter (mIU/mL).
Time frame: At Month 108 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).
Population: The analysis for persistence at month 108 was performed on the According-to-protocol (ATP) cohort analysis of immunogenicity at Year 9, which included subjects who complied with the protocol criteria and had immunogenicity results available up to the timepoint considered.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK1437173A Vaccine Group | Anti-glycoprotein (gE) Specific Antibody (Ab) Concentrations | 9122.9 mIU/mL |
Primary
Anti-glycoprotein (gE) Specific Antibody (Ab) Concentrations
Anti-gE Ab concentrations were determined by ELISA, presented as GMCs and expressed in mIU/mL.
Time frame: At Month 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).
Population: The analysis for persistence at month 120 was performed on the ATP cohort analysis of immunogenicity at Year 10, which included subjects who complied with the protocol criteria and had immunogenicity results available up to the timepoint considered.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| GSK1437173A Vaccine Group | Anti-glycoprotein (gE) Specific Antibody (Ab) Concentrations | 7384.0 mIU/mL |
Primary
Frequencies of gE (Glycoprotein)-Specific Cluster of Differentiation (CD4) (2+) T-cells.
gE specific CD4 (2+) T-cells expressing at least 2 activation markers among IFN-γ, IL-2, TNF-α and CD40L, were determined by means of Intracellular Cytokine Staining (ICS) and expressed in T-cells/million cells.
Time frame: At Month 108 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).
Population: The analysis for persistence at month 108 was performed on the ATP cohort analysis of immunogenicity at Year 9, which included subjects who complied with the protocol criteria and had immunogenicity results available up to the timepoint considered.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| GSK1437173A Vaccine Group | Frequencies of gE (Glycoprotein)-Specific Cluster of Differentiation (CD4) (2+) T-cells. | 414.0 CD4 T-cells/million cells |
Primary
Frequencies of gE (Glycoprotein)-Specific Cluster of Differentiation (CD4) (2+) T-cells.
gE specific CD4 (2+)T-cells expressing at least 2 activation markers among IFN-γ, IL-2, TNF-α and CD40L were determined by means of ICS and expressed in T-cells/million cells.
Time frame: At Month 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).
Population: The analysis for persistence at month 120 was performed on the ATP cohort analysis of immunogenicity at Year 10, which included subjects who complied with the protocol criteria and had immunogenicity results available up to the timepoint considered.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| GSK1437173A Vaccine Group | Frequencies of gE (Glycoprotein)-Specific Cluster of Differentiation (CD4) (2+) T-cells. | 401.9 CD4 T-cells/million cells |
Secondary
Anti-gE Specific Antibody (Ab) Concentrations
Anti-gE antibody concentrations were determined by ELISA in all subjects, presented as GMCs and expressed in mIU/mL.
Time frame: At 1 month post each re-vaccination dose (i.e. Month 121 and Month 123) and at 1 year post last re-vaccination dose (i.e., Month 134).
Population: The analysis was performed on the ATP cohort analysis of immunogenicity after re-vaccination, which included subjects who complied with the protocol criteria, have received at least one dose from the re-vaccination schedule and had immunogenicity results available at the timepoints considered.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK1437173A Vaccine Group | Anti-gE Specific Antibody (Ab) Concentrations | Anti-gE, Month 121 | 108199.6 mIU/mL |
| GSK1437173A Vaccine Group | Anti-gE Specific Antibody (Ab) Concentrations | Anti-gE, Month 123 | 90003.6 mIU/mL |
| GSK1437173A Vaccine Group | Anti-gE Specific Antibody (Ab) Concentrations | Anti-gE, Month 134 | 30066.2 mIU/mL |
Secondary
Anti-glycoprotein (gE) Specific Antibody (Ab) Concentrations by Each Age Category
Anti-gE Ab concentrations as determined by ELISA by each age category (60-69 years of age \[YOA\] and ≥70 YOA at the time of initial vaccination).Antibody concentrations were presented as GMCs and expressed in mIU/mL.
Time frame: At Months 108 and 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).
Population: The analysis for persistence at month 108 and 120 was performed on the ATP cohort analysis of immunogenicity at Years 9 and 10, which included subjects who complied with the protocol criteria and had immunogenicity results available at the time points considered.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK1437173A Vaccine Group | Anti-glycoprotein (gE) Specific Antibody (Ab) Concentrations by Each Age Category | Anti-gE, Month 120 | 7401.4 mIU/mL |
| GSK1437173A Vaccine Group | Anti-glycoprotein (gE) Specific Antibody (Ab) Concentrations by Each Age Category | Anti-gE, Month 108 | 8566.4 mIU/mL |
| GSK1437173A Vaccine ≥ 70 YOA Sub-group | Anti-glycoprotein (gE) Specific Antibody (Ab) Concentrations by Each Age Category | Anti-gE, Month 108 | 9259.6 mIU/mL |
| GSK1437173A Vaccine ≥ 70 YOA Sub-group | Anti-glycoprotein (gE) Specific Antibody (Ab) Concentrations by Each Age Category | Anti-gE, Month 120 | 7380.2 mIU/mL |
Secondary
Frequencies of Antigen-specific CD4 (2+) T-cells by Each Age Category
Antigen specific CD4 (2+) T-cells as determined by means of ICS and expressed in T-cells/million cells, by each age category (60-69 YOA and ≥ 70 YOA at the time of initial vaccination).
Time frame: At Months 108 and 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).
Population: The analysis for persistence at month 108 and 120 was performed on the ATP cohort analysis of immunogenicity at Years 9 and 10, which included subjects who complied with the protocol criteria and had immunogenicity results available at the timepoints considered.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK1437173A Vaccine Group | Frequencies of Antigen-specific CD4 (2+) T-cells by Each Age Category | CD4(2+), Month 108 | 453.8 CD4 T-cells/million cells |
| GSK1437173A Vaccine Group | Frequencies of Antigen-specific CD4 (2+) T-cells by Each Age Category | CD4(2+), Month 120 | 359.2 CD4 T-cells/million cells |
| GSK1437173A Vaccine ≥ 70 YOA Sub-group | Frequencies of Antigen-specific CD4 (2+) T-cells by Each Age Category | CD4(2+), Month 108 | 398.9 CD4 T-cells/million cells |
| GSK1437173A Vaccine ≥ 70 YOA Sub-group | Frequencies of Antigen-specific CD4 (2+) T-cells by Each Age Category | CD4(2+), Month 120 | 429.4 CD4 T-cells/million cells |
Secondary
Frequencies of Antigen-specific CD4 (2+) T-cells, Post Re-vaccination Course.
Antigen specific CD4 (2+)T cells were determined by means of ICS and expressed in T-cells/million cells.
Time frame: At 1 month post each re-vaccination dose (i.e. Month 121 and Month 123) and at 1 year post last re-vaccination dose (i.e., Month 134).
Population: The analysis was performed on the ATP cohort analysis of immunogenicity after re-vaccination, which included subjects who complied with the protocol criteria, have received at least one dose from the re-vaccination schedule and had immunogenicity results available at the timepoints considered.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK1437173A Vaccine Group | Frequencies of Antigen-specific CD4 (2+) T-cells, Post Re-vaccination Course. | CD4(2+), Month 121 | 2563.9 CD4 T-cells/million cells |
| GSK1437173A Vaccine Group | Frequencies of Antigen-specific CD4 (2+) T-cells, Post Re-vaccination Course. | CD4(2+), Month 123 | 1775.5 CD4 T-cells/million cells |
| GSK1437173A Vaccine Group | Frequencies of Antigen-specific CD4 (2+) T-cells, Post Re-vaccination Course. | CD4(2+), Month 134 | 1196.3 CD4 T-cells/million cells |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Assessed solicited local symptoms included: pain, redness and swelling at injection site. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest, prevented normal every day activities. Grade 3 redness/swelling = symptoms spreading beyond a surface of (\>) 100 millimeters (mm).
Time frame: Within 7 days (Days 0-6) after each vaccination and across doses, in the current study.
Population: The analysis was performed on the Total vaccinated cohort for re-vaccination course, which included all subjects with at least one dose of GSK1437173A vaccine in the current ZOSTER-060 (NCT02735915) study, who had their symptom sheets filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1437173A Vaccine Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Pain, Dose 1 | 41 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Pain, Dose 1 | 1 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Redness, Dose 1 | 19 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | >100 mm Redness, Dose 1 | 0 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Swelling, Dose 1 | 11 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | >100 mm Swelling, Dose 1 | 0 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Pain, Dose 2 | 26 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Pain, Dose 2 | 2 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Redness, Dose 2 | 17 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | >100 mm Redness, Dose 2 | 0 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Swelling, Dose 2 | 7 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | >100 mm Swelling, Dose 2 | 0 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Pain, Across doses | 46 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Grade 3 Pain, Across doses | 2 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Redness, Across doses | 27 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | >100 mm Redness, Across doses | 0 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Any Swelling, Across doses | 16 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | > 100 mm Swelling, Across doses | 0 Participants |
Secondary
Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs).
pIMDs assessed includes AEs that were autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Related pIMDs= pIMDs assessed by the investigator as related to the vaccination.
Time frame: From Dose 1 of re-vaccination (Month 120) until study end (Month 134).
Population: The analysis was performed on the Total vaccinated cohort for re-vaccination course, which included all subjects with at least one dose of GSK1437173A vaccine in the current ZOSTER-060 (NCT02735915) study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1437173A Vaccine Group | Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs). | Related pIMDs | 0 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs). | Any pIMDs | 0 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Assessed solicited general symptoms included: fatigue, gastrointestinal symptoms \[nausea, vomiting, diarrhoea and/or abdominal pain\], headache, myalgia, shivering and temperature \[higher than or equal to (≥) 37.5 degrees Celsius (°C) for axillary, oral or tympanic route\] and ≥38.0°C for rectal route. Grade 3 fatigue, gastrointestinal symptoms, headache, myalgia, shivering = symptoms that prevented normal activity. Grade 3 temperature = defined as fever higher than (\>) 39.0°C, regardless of the route used.
Time frame: Within 7 days (Days 0-6) after each vaccination and across doses, in the current study.
Population: The analysis was performed on the Total vaccinated cohort for re-vaccination course, which included all subjects with at least one dose of GSK1437173A vaccine in the current ZOSTER-060 (NCT02735915) study, who had their symptom sheets filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue, Dose 1 | 25 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue, Dose 1 | 3 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue, Dose 1 | 25 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Gastrointestinal symptoms, Dose 1 | 7 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Shivering, Across doses | 16 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | >39.0°C Temperature, Across doses | 0 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Gastrointestinal symptoms, Dose 1 | 0 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Gastrointestinal symptoms, Dose 1 | 7 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Headache, Dose 1 | 12 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache, Dose 1 | 3 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Headache, Dose 1 | 12 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Myalgia, Dose 1 | 20 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Myalgia, Dose 1 | 1 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Myalgia, Dose 1 | 19 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Shivering, Dose 1 | 12 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Shivering, Dose 1 | 2 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Shivering, Dose 1 | 12 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Temperature, Dose 1 | 9 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | >39.0°C Temperature, Dose 1 | 0 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Temperature, Dose 1 | 8 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue, Dose 2 | 15 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue, Dose 2 | 1 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue, Dose 2 | 14 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Gastrointestinal symptoms, Dose 2 | 7 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Gastrointestinal symptoms, Dose 2 | 0 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Gastrointestinal symptoms, Dose 2 | 5 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Headache, Dose 2 | 12 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache, Dose 2 | 1 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Headache, Dose 2 | 12 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Myalgia, Dose 2 | 15 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Myalgia, Dose 2 | 2 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Myalgia, Dose 2 | 14 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Shivering, Dose 2 | 8 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Shivering, Dose 2 | 2 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Shivering, Dose 2 | 8 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Temperature, Dose 2 | 8 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | >39.0°C Temperature, Dose 2 | 0 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Temperature, Dose 2 | 7 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue, Across doses | 31 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue, Across doses | 3 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue, Across doses | 31 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Gastrointestinal symptoms, Across doses | 11 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Gastrointestinal symptoms, Across doses | 0 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Gastrointestinal symptoms, Across doses | 10 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Headache, Across doses | 18 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache, Across doses | 4 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Headache, Across doses | 18 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Myalgia, Across doses | 29 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Myalgia, Across doses | 3 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Myalgia, Across doses | 27 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Shivering, Across doses | 4 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Shivering, Across doses | 16 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Temperature, Across doses | 15 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Temperature, Across doses | 13 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) According to the Medical Dictionary for Regulatory Activities (MedDRA) Classification in All Subjects.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time frame: Within 30 days (Days 0-29) after each vaccination in the current study.
Population: The analysis was performed on the Total vaccinated cohort for re-vaccination course, which included all subjects with at least one dose of GSK1437173A vaccine in the current ZOSTER-060 (NCT02735915) study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) According to the Medical Dictionary for Regulatory Activities (MedDRA) Classification in All Subjects. | Any AEs | 14 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) According to the Medical Dictionary for Regulatory Activities (MedDRA) Classification in All Subjects. | Any Grade 3 AEs | 1 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) According to the Medical Dictionary for Regulatory Activities (MedDRA) Classification in All Subjects. | Any Related AEs | 5 Participants |
Secondary
Number of Subjects With Any, Related and Fatal SAEs.
SAEs assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
Time frame: From Dose 1 of re-vaccination (Month 120) until study end (Month 134).
Population: The analysis was performed on the Total vaccinated cohort for re-vaccination course, which included all subjects with at least one dose of GSK1437173A vaccine in the current ZOSTER-060 (NCT02735915) study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1437173A Vaccine Group | Number of Subjects With Any, Related and Fatal SAEs. | Any SAEs | 7 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Related and Fatal SAEs. | Related SAEs | 0 Participants |
| GSK1437173A Vaccine Group | Number of Subjects With Any, Related and Fatal SAEs. | Any Fatal SAEs | 0 Participants |
Secondary
Number of Subjects With Any Serious Adverse Events (SAEs) Related to Study Participation or to a Concurrent GSK Medication/Vaccine (Including GSK1437173A Administered During the Zoster-003 [NCT00434577] Study).
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: Between Months 108 and 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).
Population: The analysis was performed on the Total enrolled cohort which included all subjects enrolled into the current study \[ZOSTER-060 (NCT02735915)\].
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK1437173A Vaccine Group | Number of Subjects With Any Serious Adverse Events (SAEs) Related to Study Participation or to a Concurrent GSK Medication/Vaccine (Including GSK1437173A Administered During the Zoster-003 [NCT00434577] Study). | 0 Participants |